inforMED
MalfunctionKRI

EQUAL Y CONNECTOR 1/4

Received Feb 1, 2023 · Event occurred Dec 16, 2022

Report 16277046 · MDR key 16277046

Device

Generic name

Accessory Equipment, Cardiopulmonary Bypass

Manufacturer

Novosci Corp.

Model number

C320S

Catalog number

C320S

Lot number

303897

Product problems

  • Defective Device

Patient

20440 DA · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NARRATIVE FROM STAFF: Y CONNECTOR NOT DRAINING. NOTED THAT IT WAS DEFECTIVE AND CHANGED OUT. IT WAS NOTED THAT THE CHEST TUBE NOT DRAINING WHEN EXAMINED NOTED THAT A PLASTIC BARRIER (DEFECT) INSIDE THE Y CONNECTOR WAS PREVENTING THE DRAINAGE FROM FLOWING. PATIENT PUT OUT 150ML WHEN Y CONNECTOR WAS CHANGED OUT.